Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment

March 10, 2008 updated by: Pronova BioPharma

Omacor; Omega-3-Acid Ethyl Ester 90 (n-3 PUFA) and Risk Factors in HIV Infected Patients Treated With HAART, With Special Focus on Lipids

The purpose of this study is to evaluate the effect of Omacor 4g/day on blood lipid parameters and on the function and stiffness of blood vessels in HIV infected patients on Antiretroviral Therapy (HAART)

Study Overview

Detailed Description

Results from recent studies show increasing numbers of Ischemic Heart Disease (IHD) incidents among patients on HAART treatment (Highly Active Antiviral Therapy). Three elements have received special attention:

  1. the immunodeficient effects of the HIV infection itself may influence the progression of arteriosclerosis
  2. the higher levels of risk behaviour in this group of patients (i.e. high prevalence of smokers in this group)
  3. The HAART treatment itself increases plasma levels of cholesterol, LDL cholesterol and triglycerides, resulting in HIV related lipodystrophy.

The cardioprotective effects of n-3 PUFAs are well established both through epidemiological studies and through small and large clinical trials. Clinical trials have shown positive effects of n-3 PUFA on plasma triglycerides, and statistically significant reductions in cardiovascular death and sudden cardiac death. Moreover n-3 PUFAs have been shown to have beneficial effects on endothelial function. Based on the above rationale it is expected that Omacor (Omega-3-acid ethyl ester 90) will have positive effects on risk factors related to Ischemic Heart Disease in HIV patients on HAART treatment.

Approximately 50 patients will be randomized to Omacor 4 grams/day or placebo. Treatment period is 12 weeks.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aalborg, Denmark, 9100
        • Aalborg Hospital, Department of Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Man/women > 18 years of age
  • Documented HIV infection
  • On active treatment with HAART for at least 3 months.
  • Written informed consent. This implies that the patient can read and understand Danish or English

Exclusion Criteria:

  • Age < 18 years
  • Malign disease
  • Patients assessed as not cooperative
  • Patients planning to be pregnant or who are already pregnant or breast feeding.
  • Patients who have been taking fish oil capsules prior to randomization. However, patients who have discontinued fish oil supplements at least 8 weeks prior to the first visit will be included
  • Patients allergic to fish proteins
  • Statin treatment that has been ongoing for less than three months, or a change in statin treatment dose within the last three months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Omacor capsule 1000mg x 4 per day. Duration 12 weeks
Other Names:
  • Omacor versus placebo
Active Comparator: 1
Omacor 1000mg x 4 / day
Omacor capsule 1000mg x 4 per day. Duration 12 weeks
Other Names:
  • Omacor versus placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change from week 0 (baseline) to week 12 for: Plasma triglycerides
Time Frame: baseline and 12 weeks
baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The change from week 0 (baseline) to week 12 for: Pulse Wave Velocity, Flow medicated vasodilation
Time Frame: baseline and 12 weeks
baseline and 12 weeks
HDL-cholesterol, LDL-cholesterol, total cholesterol
Time Frame: baseline and 12 weeks
baseline and 12 weeks
Inflammatory parameters: ICAM, VCAM, sensitive CRP
Time Frame: baseline and 12 weeks
baseline and 12 weeks
Apo A, Apo B, Lp(a), fibrinogen, PAI-1 ag, vw-Factor, thrombomodulin, oxidized LDL, small dense LDL, LTB4 from stimulated granulocytes
Time Frame: baseline and 12 weeks
baseline and 12 weeks
Safety parameters
Time Frame: baseline and 12 weeks
baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jeppe H. Christensen, PhD, Aalborg Hospital, Department of Nephrology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

February 23, 2006

First Submitted That Met QC Criteria

February 23, 2006

First Posted (Estimate)

February 24, 2006

Study Record Updates

Last Update Posted (Estimate)

March 11, 2008

Last Update Submitted That Met QC Criteria

March 10, 2008

Last Verified

March 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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